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J Thorac Cardiovasc Surg 2005;130:512-519
© 2005 The American Association for Thoracic Surgery
Surgery for Acquired Cardiovascular Disease |
a Department of Interventional Cardiology and Clinical Epidemiology Unit, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands
b Cardiovascular Center, OLV Hospital, Aalst, Belgium
c Division of Cardiology, University Hospital, Geneva, Switzerland
d Clinical Trials and Evaluation Unit, Royal Brompton and Harefield NHS Trust, London, United Kingdom
e Cardiothoracic Centre, Liverpool, United Kingdom
f Department of Medicine and Division of Cardiology William Beaumont Hospital, Royal Oak, Mich
g Otamendi Hospital, Buenos Aires, Argentina
h Heart Institute of the University of São Paulo, São Paulo, Brazil
i Division of Cardiovascular Diseases, Mayo Clinic and Mayo Foundation, Rochester, Minn
Received for publication March 26, 2004; revisions received December 21, 2004; accepted for publication December 23, 2004. * Address for reprints: Eric Boersma, PhD, Clinical Epidemiology Unit, Room H-543, Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Dr Molewaterplein 40, 3015 GD Rotterdam, The Netherlands (Email: h.boersma{at}erasmusmc.nl).
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Abstract |
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METHODS: An individual patient database was composed of 4 trials (Arterial Revascularization Therapies Study, Stent or Surgery Trial, Argentine Randomized Trial of Percutaneous Transluminal Coronary Angioplasty Versus Coronary Artery Bypass Surgery in Multivessel Disease 2, and Medicine, Angioplasty, or Surgery Study 2) that compared percutaneous coronary intervention with multiple stenting (N = 1518) versus coronary artery bypass graft surgery (N = 1533). The primary clinical end point of this study was the combined incidence of death, myocardial infarction, and stroke at 1 year after randomization. Secondary combined end points included the incidence of repeat revascularization at 1 year. All analyses were based on the intention-to-treat principle.
RESULTS: After 1 year of follow-up, 8.7% of patients randomized to percutaneous coronary intervention with multiple stenting versus 9.1% of patients randomized to coronary artery bypass graft surgery reached the primary clinical end point (hazard ratio 0.95 and 95% confidence interval 0.74’1.2). Repeat revascularization procedures occurred more frequently in patients allocated to percutaneous coronary intervention with multiple stenting compared with coronary artery bypass graft surgery (18% vs 4.4%; hazard ratio 4.4 and 95% confidence interval 3.3’5.9). The percentage of patients who were free from angina was slightly lower after percutaneous coronary intervention with multiple stenting than after coronary artery bypass graft surgery (77% vs 82%; P = .002).
CONCLUSIONS: One year after the initial procedure, percutaneous coronary intervention with multiple stenting and coronary artery bypass graft surgery provided a similar degree of protection against death, myocardial infarction, or stroke for patients with multisystem disease. Repeat revascularization procedures remain high after percutaneous coronary intervention, but the difference with coronary artery bypass graft surgery has narrowed in the era of stenting.
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Introduction |
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Approximately 60% of patients with CAD have symptomatic multivessel disease that could be treated by either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery.
2
Therefore, given the magnitude of the problem, a better understanding of the invasive management and clinical outcome of patients with CAD is of critical public health importance.
The last 2 decades witnessed major advances in coronary revascularization techniques for CAD, and several randomized clinical trials compared PCI against CABG surgery for the treatment of chronic, multisystem CAD.
3
In addition, 3 systematic overviews of these trials, 1 with information gathered in a standard pro forma from every principal investigator and 2 with data extracted from the published literature with intermediate and long-term follow-up outcomes, have also been reported.
4’6
However, these studies were designed in the late 1980s and conducted and reported in the early 1990s. Since then, major technologic advances have been achieved in both PCI and CABG surgery and in the recognition of the importance of risk factor reduction. The results from trials that antedated the stent era are not reflective of the current practice of coronary revascularization because coronary stents are implanted in approximately 80% of all current PCIs and adjunctive pharmacologic therapies with glycoprotein IIb/IIIa inhibitors are frequently used.
7
A systematic overview with individual patient data from recent clinical trials comparing PCI with multiple stenting against CABG surgery will provide the clinician caring for patients with multivessel CAD with meaningful treatment effect estimates regarding the advantages and drawbacks of each treatment strategy. The timing of this analysis is also advantageous, because it provides baseline data for comparisons with the results of drug-eluting stents in similar patients.
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Methods |
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Stent or Surgery Trial (SoS),
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Argentine Randomized Trial of Percutaneous Transluminal Coronary Angioplasty Versus Coronary Artery Bypass Surgery in Multivessel Disease 2 (ERACI-2),
10
Medicine, Angioplasty, or Surgery Study 2 (MASS-2),
11
and Angina With Extremely Serious Operative Mortality Evaluation (AWESOME).
12
All of these trials included patients in whom coronary revascularization was indicated and appropriate by either strategy (PCI with multiple stenting or CABG surgery) by consensus agreement between the interventionalist and cardiac surgeon. There were, however, substantial differences in trial design (Table 1). ARTS and SoS were multinational studies, ERACI-2 was a multicenter study, and MASS-2 was a single-center study. The patient population of these trials also differed in terms of comorbidity, coronary anatomy, and periprocedural risk. In ARTS, high-risk patients were excluded, and approximately two thirds of the patients enrolled had 2-vessel disease. SoS had fewer restrictions on case selection, how the procedure was to be performed, and adjunctive therapy. In ERACI-2, the study population was composed predominantly by patients with unstable angina, and patients with left main stenosis judged to be good candidates for stenting were included (
5%). Finally, the MASS-2 trial included a slightly higher number of diabetic patients and patients with 3-vessel disease compared with the other 3 trials.
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Patients with prior heart surgery, ongoing or very recent myocardial infarction (MI), and left ventricular ejection fraction less than 35% were included in AWESOME, and the characteristics of these patients are clearly different from the patient population of the 4 other trials included in this meta-analysis. Principal investigators of each study group were contacted, and individual patient data were requested regarding a broad range of baseline characteristics, medication use, procedural results, and clinical outcome. Outcome events of interest included death, MI, stroke, repeat revascularization (PCI or CABG), and anginal status to the coordinating center at the Clinical Epidemiology Unit, Thoraxcenter, Rotterdam, The Netherlands. Rigorous checks for data completeness, consistency, and agreement with the main published reports were performed, and finally an electronic database was composed consisting of individual patient data of all 4 trials.
Definitions of Variables and Clinical End Points
As expected, we found differences in clinical end point definitions in ARTS, SoS, ERACI-2, and MASS-2, especially in the definition of MI. However, we did not attempt to reclassify outcome events retrospectively, because this not only would be impractical but, more important, it also would create the potential for bias. Because the outcome definitions were the same within a particular trial and the statistical method was based on a comparison of treatment groups within each trial, no biases would be expected to result from our approach.
13
The primary clinical outcome of this meta-analysis was the composite of death, MI, or stroke at 1 year follow-up. Secondary end points included death; the composite of death or MI; repeat revascularization (PCI or CABG); and the composite of death, MI, stroke, and repeat revascularization.
Statistical Analysis
Variables are presented as median (25th, 75th percentiles) values, counts, and percentages. Differences in baseline variables between patients allocated to PCI and multiple stenting or CABG were evaluated with Fisher’s exact tests or Kruskal-Wallis tests as appropriate. Kaplan-Meier event curves were constructed, and differences between the 2 groups of patients were compared by log-rank tests. Simple Cox proportional hazard regression models were applied to further evaluate the relation between allocated treatment and the incidence of primary and secondary end points. The reported hazard ratios (HRs) and 95% confidence interval (CI) are adjusted for between-trial outcome differences, as well as for age, CAD risk factors, cardiovascular history, comorbidities, and medication. To check for statistical evidence of heterogeneity, we studied to what extent the –2 log likelihood of the regression models was improved by adding trial-allocated treatment interaction terms (
2 tests were applied). Furthermore, the consistency of treatment effects were evaluated in prespecified subgroups according to age, gender, diabetes mellitus, smoking habits, and extent of coronary disease. All analyses were performed according to the intention-to-treat principle.
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Results |
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Clinical Outcomes
Patients randomized to PCI with multiple stenting had a significantly lower incidence of death, MI, or stroke at 30-day follow-up than those randomized to CABG surgery (3.1% vs 4.8% events; HR 0.61 and 95% CI 0.42-0.89; P = .01). As shown in Table 3, this event reduction was mainly because of a lower incidence of nonfatal events. In contrast, PCI with multiple stenting was associated with an increased need for repeat revascularization procedures at 30 days (3.3% vs 0.5% repeat procedures; HR 7.8 and 95% CI 3.3-18.3; P < .001).
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Subgroup Analyses
We found no evidence of a differential treatment effect between the 2 revascularization strategies with regard to the 1-year incidence of the primary composite end point across various prognostically important subpopulations, including those grouped by age, gender, diabetes mellitus, smoking, and number of diseased vessels (Figure 3). In the subpopulation of 549 patients with diabetes mellitus, 1-year mortality occurred in 5.6% of patients allocated to PCI with multiple stenting and in 3.5% of those allocated to CABG surgery (HR 1.6 and 95% CI 0.72-3.6; P = .3).
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Discussion |
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Despite the use of stents, however, the need for repeat revascularization was considerably higher after PCI, although the observed gap with CABG surgery has narrowed from approximately 30% reported in the pre-stent era to approximately 14% in the present report.
4
Bypass surgery was still associated with a slightly lower frequency of recurrent angina, but the difference with angioplasty has decreased also in this respect.
4
One might argue that our findings are not particularly surprising because they could have been retrieved from the individual trial reports. Indeed, in the larger ARTS and SoS trials, PCI with multiple stenting and CABG surgery had similar event rates for the primary end point, whereas in ERACI-2, PCI was associated with better outcome, and in MASS-2, CABG surgery was associated with better outcome. However, substantial differences between meta-analyses of the published literature and meta-analyses of individual patient data have been reported.
14,15
The most important reason for these variations is that meta-analyses of individual patient data are based on a time-to-event analysis, whereas meta-analyses of the literature are simply based on end points at a specific point in time.
16
The direction and magnitude of these variations cannot be predicted in advance. In general, results obtained from meta-analyses of individual patient data offer least biased and more reliable treatment effect estimates, and whenever possible should be preferred over meta-analyses of the literature.
The question as to what extent the observed results can be extrapolated to routine clinical practice is challenging. We appreciate that high-risk patients with left main CAD, severe left ventricular dysfunction, and diffuse disease were not allowed to participate in the trials that were included in this meta-analysis. As a result, the median left ventricular ejection fraction in our study population was 60%, which is certainly not a representative figure of candidates for revascularization who present to an average clinic.
17
It is also important to note that an unspecified number of patients with anatomy technically unsuitable for PCI were appropriately excluded. Therefore, in routine clinical practice a higher incidence of adverse cardiac complications and repeat revascularizations should be expected than was observed in our data. Still, although absolute treatment effects may be different in clinical practice, we do not anticipate a differential relative treatment effect, because in our data relative treatment effects were similar in a broad range of prognostically important patient subgroups.
The Bypass Angioplasty Revascularization Investigation trial demonstrated a significantly higher mortality incidence at 5 (35% vs 19%) and 7 years (44% vs 24%) among diabetic patients with multivessel disease who were treated with balloon angioplasty compared with surgery.
18,19
Our data suggest that mortality may also be higher in diabetic patients with multivessel disease who undergo PCI with multiple stenting. The limited number of patients and the short duration of follow-up may have masked any significant differences. Moreover, the periprocedural use of glycoprotein IIb/IIIa inhibitors in the PCI group may have conceivably played a role in decreasing the mortality associated with PCI in our patient population.
20
With the prevalence of CAD and diabetes increasing at staggering rates, ongoing studies will provide further insights on the optimal management of multivessel disease in diabetic patients.
The widespread use of coronary stenting has significantly decreased the need for emergency CABG surgery among patients treated with PCI. The recent introduction of drug-eluting stents has decreased the incidence of coronary restenosis and the need for repeat revascularization.
21
Whether future stent technology will decrease the rates of repeat revascularization in patients with multivessel disease to rates equivalent to those after CABG surgery is a possibility that will need to be assessed in future studies. Recently published data from the RESEARCH registry have shown a significant 65% reduction in 1-year repeat revascularization in consecutive patients with multivessel disease treated with sirolimus-eluting stents compared with bare metal stents (3.7% vs 10.9% repeat procedures).
22
In this scenario, a strategy to modify the natural course of the atherosclerotic disease itself (ie, nonrestenosis-related complications) becomes the main focus of attention after percutaneous or surgical treatment of multivessel disease. Similarly, evidence is emerging that statins could decrease perioperative mortality and reduce the risk of coronary atherosclerotic events in patients undergoing PCI.
23
The main limitation of this meta-analysis is the relatively short follow-up period limited to 1 year. Long-term (5-year) follow-up of this cohort of patients is planned. It is also likely that patients included may represent a selected population of low-to-moderate risk patients with multisystem disease, thus limiting the generalizability of the results to more complex subsets of patients. It is important to note that this meta-analysis of randomized trials does not compare procedures but clinical outcomes of an initial revascularization strategy for patients who are eligible and amenable to be treated with each therapy (PCI or CABG). Moreover, because patients undergoing PCI or CABG are subsequently managed medically, late survival could not necessarily be reflective of the initial revascularization method. Finally, we realize that the differences in clinical end point definitions between the trials that were included in this meta-analysis, especially the differences in MI definitions, may complicate the extrapolation of the presented data to individual patients.
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Conclusions |
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Acknowledgments |
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References |
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